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FDA Product Code

FDA Product Code PWH — Clearance Directory

Device Class
Class II
Assigned Panel
General Hospital
21 CFR Citation
880.5440

510(k) Clearances — 4 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K221319 BD Alaris™ Pump Epidural Infusion Set Care Fusion 2023-07-21 Traditional PDF ↗
K211649 PCEA Syringe Set Baxter Healthcare Corporation 2021-11-23 Traditional PDF ↗
K172592 CADD Yellow High Volume Administration Set with NRFit connector Smiths Medical Asd, Inc. 2018-05-17 Traditional PDF ↗
K162219 CADD® Infusion Disposables Portfolio with NRFit™ connectors Smiths Medical Asd, Inc. 2017-07-20 Traditional PDF ↗

Product code PWH · Class II · General Hospital. Data: openFDA.